MILESTONES
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Ordoñez
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In September, Celera (Rockville, MD), the molecular diagnostics business unit of Applera Corp. (Norwalk, CT), and Atria Genetics Inc. (South San Francisco, CA) announced that the companies have signed a definitive agreement under which Celera will acquire substantially all of the assets of Atria for about $33 million in cash. Atria has a line of human leukocyte antigen testing products that are used for identifying potential donors in the matching process for bone marrow transplantation. Earlier in September, Celera announced its plan to purchase cardiovascular healthcare company Berkeley HeartLab Inc. (Burlingame, CA) for about $195 million in cash. Since the October completion of the acquisition, Berkeley HeartLab has been operated as a business unit of Celera. "This acquisition provides Celera with a commercial infrastructure to drive adoption of many of its emerging new molecular diagnostic tests that predict risk and individualize treatment in cardiovascular disease," said Kathy Ordoñez, president of Celera. "Celera's genetic markers that are intended to identify people at risk for early heart attacks, stroke, and blood clots, and optimize therapy with cholesterol-lowering drugs, aspirin, anticoagulants, and other cardiovascular drugs, should augment Berkeley HeartLab's current disease management offerings to patients."
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Krauss
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GlucoLight Corp. (Bethlehem, PA), a development-stage company focused on blood glucose monitoring in the acute-care environment, has been awarded a U.S. patent for the technology that is the core of the company's first product, the Sentris-100 glucose monitor. The patent focuses on optical coherence tomography—based technology to noninvasively monitor the concentration of glucose in the blood. "The award of our first patent is an important milestone for us as we pursue clinical testing of all aspects of our monitor, and make corresponding design and technological adjustments," said Ray Krauss, CEO of GlucoLight.
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Grube
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Stentys (Paris), which has developed a next-generation drug-eluting stent for treatment of blocked coronary artery bifurcations, announced that its stent was successfully implanted into its first patient, a 56-year-old male in Siegburg, Germany. "The Stentys platform offers great promise in treating blocked coronary artery bifurcations as simply and effectively as a conventional stenting procedure," said Eberhard Grube, MD, chief of cardiology and angiology at Helios Klinikum Siegburg and a consulting professor of medicine at Stanford University.
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Smith
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Flexible Medical Systems, a privately held medical device company focused on remote diagnostics capabilities for early disease detection, painless management of chronic diseases, and improved economics for patients and doctors, announced that it has completed the private placement of $1.2 million of common equity to a group of accredited investors. The company will use the proceeds from the private placement to conduct human proof-of-concept trials, to pursue additional intellectual property filings, and for general working capital. "The proceeds from this investment will provide us with funding to pursue our business plan," said Richard H. Smith, president of Flexible Medical Systems. "We intend to demonstrate our proven animal study results in humans, which will allow us to go to the next level." The company plans to occupy labs in Rockville, MD.
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Steward
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AdvanDx Inc. (Woburn, MA) has closed a $15 million series C financing round from new investor bioMérieux (Marcy l'Etoile, France) and existing investors LD Pensions and SLS Venture. This latest financing will be used to accelerate the commercialization of AdvanDx's product pipeline through its global sales and marketing operations as well as to expand its research and development activities. The funding follows the recent announcement of AdvanDx's exclusive distribution partnership with bioMérieux for its PNA FISH rapid in vitro diagnostic products for positive blood cultures in the United States. "We are very excited about AdvanDx's molecular diagnostic capabilities and the future of what this partnership can deliver," said Herb Steward, executive vice president of bioMérieux. "AdvanDx's current products perfectly complement our solutions that help hospitals manage patients with bloodstream infections."
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Fert
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Xenomics Inc. (New York City), a developer of medical DNA diagnostic technologies, has signed a licensing agreement with Ipsogen SAS (Marseilles, France), a molecular diagnostics company, for the coexclusive rights to develop, manufacture, and market research and diagnostic products for the stratification and monitoring of patients with acute myeloid leukemia. "This agreement with Xenomics, a leading company developing innovative DNA-based tests, enables Ipsogen to further expand its unique range of diagnostic products dedicated to the disease management of blood cancers," said Vincent Fert, president and CEO of Ipsogen.
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Kersey
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CAS Medical Systems Inc. (Branford, CT), a medical device company focused on noninvasive vital signs monitoring, has been awarded a Phase IIb small business innovative research grant by the National Institute of Neurological Disorders and Stroke, a component of the National Institutes of Health. The three-year grant, totaling $2.8 million, will be used primarily to support advanced clinical outcome studies that focus on the company's proprietary Laser-Sight technology, which is incorporated into the Fore-Sight cerebral oximeter. The Fore-Sight started shipping to distributors and customers in the second quarter of 2007. Further clinical studies funded by the new grant will be used to expand the clinical applications for Fore-Sight outside of the initial target market of high-risk cardiovascular surgery. "We are pleased with our early market response and success with Fore-Sight and our customers' understanding of the benefits of absolute cerebral oximetry," said Andrew E. Kersey, president and CEO of CAS Medical Systems.
Arbios Systems Inc. (Pasadena, CA), a biomedical device and cell therapy company developing liver-assist products for the treatment of liver failure, announced positive results from the completed feasibility clinical trial of its Sepet liver-assist device, in which 79% of patients met the primary clinical effectiveness endpoint. Arbios's Sepet device is a large-pore blood filter that is being studied in chronic liver disease patients for its potential to promote improvements in liver function following acute exacerbation of liver failure. "The successful completion of this study serves as the foundation for developing an appropriately powered, randomized, controlled pivotal clinical trial of Sepet," said Walter Ogier, former president and chief executive officer of Arbios. "The excellent final results of the feasibility trial, and their acceptance for oral presentation at the International Symposium on Albumin Dialysis in Liver Disease, also gives the company further confidence in seeking potential earlier commercialization of the Sepet device in Europe under the CE mark."
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Sullivan
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The inReach system, developed by superDimension (Minneapolis), has received 510(k) clearance from FDA. The system provides electromagnetic navigation and guidance to distant regions of the lungs in a minimally invasive manner. The company also recently raised nearly $21 million in venture capital to expand its sales, marketing, and operations. "InReach assists physicians in reaching distant locations in the lungs, helping patients avoid more-invasive procedures for diagnosing cancer," said Dan Sullivan, superDimension's chief executive officer. "Many years ago, the angiogram transformed cardiac care because for the first time doctors could diagnose and treat the heart without opening the chest. We believe inReach can have the same dramatic effect on the pulmonology field, providing an option for patients with lesions that previously were unreachable."
Laparoscopic systems manufacturer Viking Systems Inc. (San Diego) has signed a letter of intent to acquire Tuebingen Scientific Medical GmbH (Tübingen, Germany), a developer of articulating surgical instrumentation for minimally invasive surgery that markets its instruments under the brand name Radius. The transaction, terms of which were not disclosed, represents a strategic shift for Viking Systems designed to significantly expand its addressable market and accelerate the company's revenue growth. "Tuebingen Scientific's line of articulating surgical instruments, combined with Viking's 3D vision technologies and our Infomatix platform, will allow us the opportunity to offer a new and powerful solution set to the market," said Donald E. Tucker, CEO and president of Viking Systems. "With this business combination, Viking Systems would add significant clinical value to our existing technology and offerings, as well as a new and highly synergistic revenue stream to the business. The business combination will also support our entry into new clinical markets, including cardiovascular, cardiothoracic, and general pediatric surgery." The company expects to complete a definitive agreement, funding for the deal, and the acquisition by the end of the year.
